HeartMate 3™ CE Mark Clinical Investigation Plan

Inclusion Criteria:

1. Patient or legal representative has signed Informed Consent Form (ICF)
2. Age ≥ 18 years
3. BSA ≥ 1.2 m2
4. NYHA IIIB or IV OR ACC/AHA Stage D
5. LVEF ≤ 25%
6. CI ≤ 2.2 L/min/m2, while not on inotropes
7. Patients must also meet one of the following:

• On Optimal Medical Management (OMM), based on current heart failure practiceguidelines for at least 45 out of the last 60 days and are failing to respond, OR
• In NYHA class IIIB or IV heart failure for at least 14 days AND dependent onintraaortic balloon pump (IABP) for at least 7 days, OR
• Inotrope dependent/unable to wean from inotropes OR
• Listed for Transplant

8. Females of child bearing age must agree to use adequate contraception

Exclusion Criteria:

1. Etiology of HF due to or associated with uncorrected thyroid disease, obstructivecardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
2. Technical obstacles which pose an inordinately high surgical risk, in the judgment ofthe investigator
3. Existence of ongoing mechanical circulatory support (MCS) other than IABP
4. Positive pregnancy test if of childbearing potential
5. Lactating mothers
6. Presence of mechanical aortic cardiac valve that will not be converted to abioprosthesis at the time of LVAD implant
7. History of any organ transplant
8. Platelet count < 100,000 x 103/L (< 100,000/ml)
9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocialissues that are likely to impair compliance with the study protocol and LVASmanagement
10. History of confirmed, untreated AAA > 5 cm in diameter
11. Presence of an active, uncontrolled infection
12. Intolerance to anticoagulant or antiplatelet therapies or any otherperi/post-operative therapy the investigator will require based upon the patients'health status
13. Presence of any one of the following risk factors for indications of severe end organdysfunction or failure:
14. An INR ≥ 2.5 not due to anticoagulation therapy
15. Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven livercirrhosis
16. History of severe chronic obstructive pulmonary disease (COPD) defined byFEV1/FVC < 0.7, or FEV1 <50% predicted
17. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that isunresponsive to pharmacologic intervention
18. History of stroke within 90 days prior to enrollment, or a history ofcerebrovascular disease with significant (> 80%) carotid artery stenosis
19. Serum creatinine ≥221umol/L (2.5 mg/dl) or the need for chronic renal replacementtherapy
20. Significant peripheral vascular disease (PVD) accompanied by rest pain orextremity ulceration
21. Patient has moderate to severe aortic insufficiency without plans for correctionduring pump implant
22. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL)
23. Planned Bi-VAD support prior to enrollment
24. Patient has known hypo or hyper coagulable states such as disseminated intravascularcoagulation and heparin induced thrombocytopenia
25. Participation in any other clinical investigation that is likely to confound studyresults or affect the study
26. Any condition other than HF that could limit survival to less than 24 months